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CTRI Number  CTRI/2024/05/067944 [Registered on: 27/05/2024] Trial Registered Prospectively
Last Modified On: 25/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Effect of Awareness on Menstrual Hygiene Knowledge and Practice]  
Study Design  Single Arm Study 
Public Title of Study   A study to find the efficacy of Awareness done in adolescent girls of school on topic Menstrual Hygiene Knowledge and Practice 
Scientific Title of Study   Effect of School Based Awareness on Menstrual Hygiene Knowledge and Practice among Adolescent Girls 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrNandiniM 
Designation  PG Scholar,Department of Swasthavritta 
Affiliation  Government Ayurveda Medical College and Hospital 
Address  Government Ayurveda Medical College and Hospital, Pulimoodu junction,Thiruvananthapuram

Thiruvananthapuram
KERALA
695001
India 
Phone  8289838187  
Fax    
Email  nandini16051994@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrNandiniM 
Designation  PG Scholar,Department of Swasthavritta 
Affiliation  Government Ayurveda Medical College and Hospital 
Address  Government Ayurveda Medical College and Hospital, Pulimoodu junction,Thiruvananthapuram

Thiruvananthapuram
KERALA
695001
India 
Phone  8289838187  
Fax    
Email  nandini16051994@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrSheelaS 
Designation  Professor and HOD,Department of Swasthavritta 
Affiliation  Government Ayurveda Medical College and Hospital 
Address  Government Ayurveda Medical College and Hospital, Pulimoodu junction,Thiruvananthapuram

Thiruvananthapuram
KERALA
695001
India 
Phone  9847706888  
Fax    
Email  drsheelas@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurveda Medical College and Hospital,Pulimoodu Junction,Thiruvananthapuram-695001,Kerala,India 
 
Primary Sponsor  
Name  NandiniM 
Address  PG Scholar,Government Ayurveda Medical College and Hospital,Pulimoodu Junction,Thiruvananthapuram-695001 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrNandiniM  Government Ayurveda Medical College and Hospital,Pulimoodu Junction,Trivandrum  Department of Swasthavritta,OP no:2,Government Ayurveda Medical College and Hospital,Thriuvananthapuram-695001
Thiruvananthapuram
KERALA 
8289838187

nandini16051994@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC) Government Ayurveda College Thiruvananthapuram  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Participants who has attained menarche 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmLifestyle--Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Awareness on Menstrual Hygiene Knowledge and Practice among adolescent girls for consecutive 3 months, Pathya/Apathya:, Pathya:, Apathya:
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  17.00 Year(s)
Gender  Female 
Details  Adolescent girls of age group 12-17 years who has attained menarche selected after getting written informed consent from parents 
 
ExclusionCriteria 
Details  Adolescent girls who are mentally challenged
Schools in which Awareness on Menstrual Hygiene Knowledge and Practice has been given on the same academic year in which study is going to be conducted 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Effect of Awareness  0th day,90th day 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  NIl 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   28/06/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

                Menstruation is an essential phenomenon in an adolescent girl’s life and it is a complex biological phenomenon governed by the interplay of hormones, particularly estrogen and progesterone, which prepare the uterine lining for potential pregnancy.According to the WHO/UNICEF Joint Monitoring Programme 2012, menstrual hygiene management is defined as: 

“Women and adolescent girls are using a clean menstrual management material to absorb or collect menstrual blood, that can be changed in privacy as often as necessary, using soap and water for washing the body as required, and having access to safe and convenient facilities to dispose of used menstrual management materials. They understand the basic facts linked to the menstrual cycle and how to manage it with dignity and without discomfort or fear.”

                    90 samples will be selected as per inclusion and exclusion criteria by simple random sampling from selected Government schools in urban region of Thiruvananthapuram district of Kerala state. Before taking survey, authority consent will be taken from school authority for conducting the study. Then informed consent will be obtained from the parents of the participants and assent from participants who are selected by simple random sampling. The data will be collected as pre-survey procedure through direct interview schedule with the help of a pre-validated structured questionnaire.[16]. The participant will be assured about the confidentiality of any kind of data obtained through the survey. After collecting data ,an Awareness class on Menstrual Hygiene Knowledge and Practice will be given to the participants which deals the areas like basics of menstruation with physiology, physical and psychological changes during menstruation, personal hygiene and its importance,nutritional status during menstruation, menstruation material to be used and its cleaning and changing time, problems associated with menstruation and mode of utilisation of ayurvedic measure for solving the issues etc to the participants; which will be given as 3 sessions during 3 consecutive menstrual cycle of the participants. Later the same questionnaire will be given to the participant for taking post-survey after first menstrual cycle following the Awareness class. Taking post-survey result ,analysis of pre-survey and post-survey result will be done to analyse the effectiveness of Awareness on Menstrual Hygiene Knowledge Practice among the  participants.

 
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